Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Vials (NDC 0641-6145-01), packaged i...
FDA Recall #D-0093-2018 — Class III — November 6, 2017
Product Description
Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Vials (NDC 0641-6145-01), packaged in 25 x 1 mL Vials per shelf pack (NDC 0641-6145-25), Rx Only, Manufactured by WEST-WARD, Eatontown, NJ 07724 USA.
Reason for Recall
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Recalling Firm
West-Ward Pharmaceuticals Corp. — Eatontown, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
16,157 shelf packs
Distribution
Nationwide in the USA and Puerto Rico
Code Information
Lot #: 106390, 106393, 106395, Exp 10/18
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated